(56 days)
· Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
· Remove smear layer of dentin and enamel
• Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
The provided text is a 510(k) premarket notification for a dental etchant called "FineEtch." It discusses the device's classification, indications for use, comparison to a predicate device, and performance testing. However, it does not include the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML device.
Specifically, the document states: "9. Performance Testing-Clinical tests Not Applicable". This indicates that no clinical studies, which would typically involve human subjects or human readers (as implied by questions 3-5), were conducted or submitted for this device. The non-clinical tests mention pH, viscosity, shape retention, and etching effect, comparing the device to a predicate and another dental etchant. This type of testing is characteristic of a substance or instrument, not an AI/ML diagnostic or assistive device that would rely on human expert interpretation of data.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, ground truth establishment, expert consensus, MRMC studies, or training/test set details, as this document pertains to a chemical dental product, not an AI/ML software device.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.